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NOT YET RECRUITING
NCT06765993
PHASE2/PHASE3

Efficacy and Safety of Isosorbide Oral Solution in Patients With Meniere's Disease

Sponsor: Lunan Better Pharmaceutical Co., LTD.

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the efficacy and safety of isosorbide oral solution compared with placebo in people with unilateral Meniere's disease. A total of approximately 234 subjects will be enrolled in this study: 72 subjects in phase Ⅱ and approximately 162 subjects in phase Ⅲ. Patients were randomly assigned to either the experimental group or the control group. The randomization ratios for phase Ⅱ and phase Ⅲ were 1:1 and 2:1, respectively.

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II/III Clinical Study of Isosorbide Oral Solution in the Treatment of Meniere's Disease

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

234

Start Date

2024-12-30

Completion Date

2027-12-30

Last Updated

2025-01-09

Healthy Volunteers

No

Interventions

DRUG

Isosorbide oral solution

30 mL, TID

DRUG

Placebo

30 mL, TID